FERTILITY DRUGS AND OVARIAN CANCER
NIH GUIDE, Volume 22, Number 31, August 27, 1993
RFP AVAILABLE: NICHD-CRE-93-12
P.T. 34
Keywords:
Human Reproduction/Fertility
Pharmaceuticals
Cancer/Carcinogenesis
National Institute of Child Health and Human Development
The Contraceptive and Reproductive Evaluation Branch, National
Institute of Child Health and Human Development (NICHD), seeks
sources for a study of the long-term sequelae of exposure to
fertility drugs. The primary objective is to determine whether and,
if so, to what degree, exposure to ovulation-inducing drugs increases
the risk of ovarian cancer. The secondary objective is to shed light
on other potentially serious adverse effects of ovulation induction.
The proposed cohort study would involve subjects from one or more
well-defined historic cohorts with data already collected on
reproductive, personal, familial, and any other relevant risk
factors, including complete fertility drug history (dosage and
duration of usage), as well as histological diagnoses of any
malignancies occurring among the participants. Enough women must
have been already enrolled to ensure sufficient statistical power to
test hypotheses in subsets of the data, such as anovulatory versus
other forms of infertility and women of different parity and
gravidity. Due to the relative rarity of ovarian cancer, all
interested parties must be able to document the existence of an
historic cohort currently providing at least 30,000 woman-years of
follow-up after exposure. This requirement is based on available
incidence data to detect a three-fold difference in risk of ovarian
cancer. Offerors should have expertise in the field of reproductive
epidemiology, particularly with regard to ovulation induction and
ovarian cancer. Offerors should also have experience in assembling
and obtaining adequate follow-up of large cohorts and in collecting,
managing, and analyzing large epidemiologic data bases. The
Government estimates the effort to be approximately 4.5 technical
staff-years. It is anticipated that one cost-reimbursement
incrementally funded type contract will be awarded for a period of 54
months.
INQUIRIES
This announcement is not a request for proposals (RFP). RFP No.
NICHD-CRE-93-12 is now available. Copies of the RFP may be obtained
by sending a written request, with a self-addressed label, or a FAX
request to:
Charles W. Grewe, Contracting Officer
Office of Grants and Contracts
National Institute of Child Health and Human Development
6100 Building, Room 7A07
Bethesda, MD 20892
FAX: (301) 402-3676
.